Actively Recruiting
Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
Led by Peking Union Medical College Hospital · Updated on 2026-01-29
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diminished Ovarian Reserve (DOR) is a condition characterized by a reduced number of recruitable follicles and/or decreased oocyte quality, affecting women's fertility and potentially leading to Premature Ovarian Failure within 1 to 6 years if untreated. This study is a single-center, prospective, randomized, controlled clinical trial investigating the effects of acupoint photodynamic therapy and traditional Chinese medicine on improving ovarian reserve. It aims to clarify treatment roles, explore new metabolic biomarkers, and understand mechanisms behind these therapies in DOR patients. Participants will be randomly assigned to one of three groups: acupoint photodynamic therapy combined with Dingkun Dan (a traditional Chinese medicine), acupoint photodynamic therapy combined with a placebo, or Dingkun Dan alone. The phototherapy involves daily 20-minute treatments at specific acupoints for five days per cycle, repeated until the next menstruation, while Dingkun Dan or placebo is taken orally twice daily for 21 days each month over three months. During the study, clinical data and serum metabolomics will be collected at baseline and after three months of treatment. Researchers will measure changes in hormone levels such as anti-Müllerian hormone, follicle-stimulating hormone, and antral follicle count, along with biochemical markers, menstrual blood loss, traditional Chinese medicine syndrome scores, and quality of life. The study includes safety monitoring and aims to assess treatment effects through these comprehensive evaluations over the treatment period.
CONDITIONS
Brief Title
Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 25 to 40 years
- Diagnosed with diminished ovarian reserve, meeting at least two of the following: Basal FSH 10-25 IU/L, AMH < 1.1 ng/mL, AFC < 7
- Diagnosed with kidney deficiency syndrome according to traditional Chinese medicine
- Willing to participate and provide written informed consent
You will not qualify if you...
- Presence of organic lesions such as ovarian tumors, pituitary adenomas, endometrial tuberculosis, intrauterine adhesions, or endometrial damage after abortion
- Diagnosed with polycystic ovary syndrome, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or thyroid dysfunction
- Treated with sex hormones within the past 3 months
- Serious or unstable diseases affecting liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune, hematological, or psychiatric systems
- History of substance abuse or dependence in the past 3 months or heavy smoking (20 or more cigarettes per day)
- Allergy to the investigational drug or photosensitivity, or contraindications to Dingkun Dan
- Participation in another clinical trial of an investigational drug within the past month
- Other conditions judged by investigators that may reduce enrollment likelihood or complicate follow-up, such as frequent job changes or risk of loss to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either acupoint photodynamic therapy, traditional Chinese medicine, or a combination of both to improve ovarian reserve function.
Daily sessions for 5 days per cycle with 2-day intervals between cycles, plus twice daily oral medication for 21 days per month, repeated for 3 cycles
Trial Site Locations
Total: 1 location
1
Peking union medical college hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yingying Guo, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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